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Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Children's Zyrtec(R) Chewable Tablets for Allergy Relief and Children's Zyrtec(R) Chewable Tablets for Hives Relief
Date:1/14/2008

DETROIT, Jan. 14 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, "over-the-counter", (OTC), 5 mg and 10 mg (Cetirizine HCl Chewable).

Cetirizine HCl Chewable, which will be marketed as two separate OTC products in two strengths, 5 mg and 10 mg, is an antihistamine drug, which is used to treat allergies, hives, and other allergic inflammatory conditions. These new products are bioequivalent to Children's Zyrtec(R) chewable tablets for allergy relief and Children's Zyrtec(R) for hives relief, registered trademarks of Johnson & Johnson.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this FDA final approval for our second generic "over-the-counter" product to be added to our current portfolio of prescription products. We feel that Cetirizine HCl Chewable complements our previously announced FDA final approval of Cetirizine Hydrochloride Tablets, 5 mg and 10 mg, and both products will be positive additions to our portfolio by expanding our product offerings. Children's Zyrtec(R) chewable tablets for allergy relief have just been approved for the OTC market and we are pleased to be able to market a generic OTC version as an alternative. It previously was marketed strictly as a prescription product under the Zyrtec(R) brand name, a registered trademark of Pfizer Inc. where it had done over $80 million in prescription sales. We plan to market these products to the generic pharmaceutical and OTC markets immediately."

Detroit-based Caraco Pharmaceutical Labor
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SOURCE Caraco Pharmaceutical Laboratories, Ltd.
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